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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC(R) THERA(TM) PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS037
Date Received04/06/1995
Decision Date10/31/1995
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFIED REDUCED SIZE VERSIONS OF THE THERA DR (APPROVED UNDER P890003/S31). THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME:MEDTRONIC THERA-I SERIES AND PRODIGY PULSE GENERATORS, MODEL 9879 SOFTWARE, AND MODELS 9759/9772 MEMORYMODS.
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